Manager - Regulatory Affairs (Hybrid) - Tempe, AZ

We are seeking a Regulatory Affairs Analyst to support our medical devices and in-vitro diagnostic products. The successful candidate will have experience in regulated environments and knowledge of domestic and international medical device regulations. · ...

Support regulatory activities related to medical devices/in vitro diagnostic products. · ...

The Regulatory Affairs (RA) Specialist will provide primary RA support for one or more product lines and/or region(s), including independent participation on new product development teams and continued RA support through the lifecycle of the product. · We are seeking a highly mot ...

The Director Regulatory Affairs is responsible for developing and executing the global regulatory strategy for Stryker Sustainability Solutions business unit.Lensa does not hire directly for these jobs, but promotes jobs on LinkedIn on behalf of its direct clients, recruitment ad ...

As a Regulatory Affairs Analyst at Caris Life Sciences you will be responsible for regulatory activities related to medical devices/ in vitro diagnostic products including supporting regulatory compliance activities for US and international regions. · ...

The Regulatory Affairs (RA) Specialist will provide primary RA support for one or more product lines and/or region(s), including independent participation on new product development teams and continued RA support through the lifecycle of the product. · ...

The Regulatory Affairs Engineer role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies. · ...

The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions. · ...

The Regulatory Affairs Associate role is responsible for assisting with preparing and submitting the appropriate documentation for pre-market submissions. · ...

+ Develop and execute global regulatory strategies for Class II devices + Serve as the primary regulatory authority on product development teams providing strategic input from concept through commercialization + Act as the primary company representative in all interactions with t ...

The Regulatory Affairs Engineer is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies. · ...

+Job summary · The Regulatory Affairs Specialist role is responsible for preparing and submitting documentation for FDA 510(k) submissions.++•Ability to work in a fast paced collaborative team environment+•Ability to handle multiple projects and coordinate cross functional teams+ ...

+The Regulatory Affairs Associate role is responsible for assisting with preparing and submitting the appropriate documentation for pre-market submissions (i.e. FDA 510(k) submissions, Health Canada Device License Applications). · +Minimum of Bachelor's degree preferably in Engin ...

We are seeking an accomplished Regulatory Affairs Manager with hands-on regulatory experience to architect and drive regulatory strategy for our most complex products. · ...

We are seeking an accomplished Regulatory Affairs Manager with hands-on regulatory experience to architect and drive regulatory strategy for our most complex products. This role is pivotal in shaping the regulatory landscape for our portfolio, navigating novel regulatory pathways ...

We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Join us in our mission to improve the human condition across multiple diseases. · ...

The Regulatory Affairs Senior Specialist is responsible for product remediation projects and the preparation of regulatory submissions required to legally market medical devices in the European Union under the MDR. · This role will provide support for global product registrations ...

The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies. This position requires a minimum of five years medical device regulatory experi ...

+We are seeking a Manager - Regulatory Affairs to join our team. This role will be responsible for regulatory activities related to medical devices / in vitro diagnostic projects and applicable health authority submissions. · +Lead as the RA representative on project core teams p ...

Job summaryThe Regulatory Affairs Associate will focus on supporting the registration, · compliance, and documentation of bio-based products across national and international markets. · ...